STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

  • AWDHUT PIMPALE Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, India.
  • RAJENDRA KAKDE Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, India.

Abstract

Objective: The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin (RSV) calcium and clopidogrel bisulfate (CLO) in bulk and tablet formulation.


Methods: The separation was attained on RP Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5 μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid), and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of RSV calcium and CLO was found to be 2.844 min and 4.388 min, respectively.


Results: The linearity of the method was demonstrated in the concentration range of 6–16 µg/ml and 45–120 µg/ml for RSV calcium and CLO with a correlation coefficient (r2) of 0.9999 and 0.9996, respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12–101.37% and 99.72–101.09% for RSV calcium and CLO, respectively. Assay of marketed tablet formulation was found to be 98.99% and 99.92%, respectively.


Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of RSV calcium and CLO in bulk and tablet formulations.

Keywords: Rosuvastatin calcium, Clopidogrel bisulfate, Reversed-phase high-performance liquid chromatography, Validation, International conference on harmonization guidelines

References

1. The United States Pharmacopeia. National Formulary 24, US Pharmacopeal Convention; 2007. p. 796.
2. Available from: https://www.en.wikipedia.org/wiki/rosuvastatin.
3. The United States Pharmacopeia. National Formulary 24, US Pharmacopeal Convention; 2007. p. 1280.
4. Available from: https://www.en.wikipedia.org/wiki/clopidogrel.
5. Sailaja B, Kumari KS. Stability-indicating method development and validation for the estimation of rosuvastatin calcium in bulk and tablet formulation by reverse-phase high-performance liquid chromatography. Asian J Pharm Clin Res 2019;12:251-6.
6. Pathan M, Kshirsagar A. Development of validated stability indicating method by RP-HPLC for simultaneous estimation of meropenem and vaborbactam in bulk and pharmaceutical formulation. Int J Pharm Pharm Sci 2019;11:102-8.
7. Rajesh R, James JJ. A validated RP-HPLC method for simultaneous estimation of pyrantel pamoate and praziquantel in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci 2019;11:62-7.
8. Al-Bathish MY, Gazy AA, El-Jamal MK. RP-HPLC and chemometric methods for the determination of two anti-diabetic mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide in their pharmaceutical formulation. Int J Pharm Pharm Sci 2020;12:83-94.
9. Damle MC, Waghmare SS, Sinha P. Development and validation of stability indicating HPTLC method for determination of apixaban as bulk drug. Int J Pharm Pharm Sci 2019;11:37-42.
10. Aher SS, Saudagar RB, Kothari H. Development and validation of RP-HPLC method for simultaneous estimation of azilsartan medoxomil and chlorthalidone in bulk and tablet dosage form. Int J Curr Pharm Res 2018;10:21-4.
11. Choppella V, Badipati S, Gonthina H, Chukka VK. Stability indicating method development and validation for simultaneous quantification of sorafenib and regorafenib drug substances by using RP-UPLC. Int J Curr Pharm Res 2020;12:56-62.
12. Chengalva P, Kuchana M. Stability indicating UPLC method for simultaneous determination of phenylephrine hydrochloride, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine hydrochloride in bulk and pharmaceutical formulation. Int J Appl Pharm 2019;11:284-92.
13. Kuchana M, Kandukuru C, Chengalva P. Development and validation of RP-HPLC method for simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and pharmaceutical dosage form. Int J Appl Pharm 2020;12:134-8.
14. Rajput P, Shah DB, Maheshwari DG. A review on chromatographic method for estimation of rosuvastatin calcium. Int J Res Pharm Pharm Sci 2018;3:28-31.
15. Thammera RK, Shitut NR, Pasikanti KK, Menon VC, Venkata VP, Mullangi R. Determination of rosuvastatin in rat plasma by HPLC and its application to pharmacokinetic studies. Biomed Chromatogr 2006;20:881-7.
16. Hassouna ME, Salem HO. Stability indicating new RP-HPLC method for the determination of rosuvastatin calcium in pure and tablets dosage forms. Int J Appl Pharm Biol Res 2017;2:11-27.
17. Mulukuri NV, Srinivasarao T, Raveendra BG. New RP-HPLC method development and validation for the estimation of rosuvastatin calcium in bulk drugs and formulations. J Pharm Res 2017;11:257-60.
18. Hasumati AR, Rajput SJ, Dave JB, Patel CN. Development and validation of two chromatographic stability-indicating methods for determination of rosuvastatin in pure from and pharmaceutical preparation. Int J ChemTech Res 2009;1:677-89.
19. Trivedi HK, Patel MC. Development and validation of a stability-indicating RP-UPLC method for determination of rosuvastatin and related substances in pharmaceutical dosage form. Sci Pharm 2012;80:393-406.
20. Singh SS, Sharma K, Patel H, Jain M, Shah H, Gupta S. Estimation of rosuvastatin in human plasma by HPLC tandem mass spectroscopic method and its application to bioequivalence study. J Braz Chem Soc 2005;16:944-50.
21. Bahrami G, Mohammadi B, Mirzaeei S, Kiani A. Determination of atorvastatin in human serum by reversed-phase high performance liquid chromatography with UV detection. J Chromatogr B 2005;826:41-5.
22. Panchal HJ, Suhagia BN, Patel NJ, Rathod IS, Patel BH. Simultaneous estimation of atorvastatin calcium, ramipril and aspirin in capsule dosage form by RPLC. Chromatographia 2009;69:91-5.
23. Kadav A, Vora DN, Stability indicating UPLC method for simultaneous determination of atorvastatin calcium, fenofibrate and their degradation products in Tablets. J Pharm Biomed Anal 2008;48:120-6.
24. Madala A, Keerthisikha P. A new stability indicating method development and validation of RP-HPLC method for the simultaneous estimation of rosuvastatin calcium and fenofibrate in tablet dosage form. Indo Am J Pharm Sci 2016;3:953-9.
25. Rajput SJ, George RK, Ruikar DB. Chemometric simultaneous estimation of clopidogrel bisulfate and aspirin from combined dosage form. Indian J Pharm Sci 2008;70:450-4.
26. Chaudhari PB, Pawar PD, Narkhede KP. Stability indicating spectrophotometric method for determination and validation of clopidogrel bisulfate in tablet dosage form. Int J Res Ayureda Pharm 2010;1:418-23.
27. Himani A, Neeraj K, Paradkar AR, Mahadik KR. Stability indicating HPTLC determination of method for clopidogrel bisulfate as bulk drug and in pharmaceutical dosage form. J Pharm Biomed Anal 2003;61:581-9.
28. International Conference on Harmonisation. Stability Testing of New Drug Substances and Products. Geneva: Proceedings of the International Conference on Harmonisation; 1993.
29. Available from: https://www.ich.org/fileadmin/public_web_site/ich_ products/guidelines/quality/q2_r1/step4/q2_r1_guideline.pdf.
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PIMPALE, A., and R. KAKDE. “STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 9, June 2020, pp. 84-90, doi:10.22159/ajpcr.2020.v13i9.38013.
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